Flipper44 said, "I anticipate the phase 2 will be much larger because not many people are going to die -- not many at all."
There is no reason to link size of a trial with how many are anticipated will or will not die. There is a basic misunderstanding somewhere in that assumption. Size of the trial is relevant to diversity of subtypes, powering especially and of course, FUNDING! And overall survival will always remain irrelevant in single arm studies. To everyone except longs of the company in question, that is.
Also, stating you're anticipating "not many at all" will die in the trial is something no oncologist or researcher would do. It exhibits unrealistic optimism, which after all is also groundless. The P1 DCVax-Direct study proved the vaccine is powerless to prevent progression of disease. If DC were truly picking up antigens, expressing them to and inducing t-cells, and thereby provoking an immune response, then there should be SOME significant shrinkage or AT LEAST a halting of progression. Yet it is clear that over 85% of the patients in this trial (yes, even"Method B" patients) showed clear progression of disease in under 4 months. It's just not working. Maybe some cytokine release is causing pockets of necrosis, but that appears to be it. Intratumorally injected chemos can do better than that.
RKmatters said, "They tested 15mm dosing in 3 patients. Day 0, Day 7, Day 14. That's 45 mm cells there and didn't even reach a MTD."
No DLT is a separate issue only partly related to the safety profile of a drug. I specifically said SAE.
RK: "They plan to test with 2mm cell x 3 injections = 6 mm cells bMore math coming for you, please keep up.
45 mm / 6 mm = 9 injections."
LOL, some fuzzy math. But don't worry I'm "keeping up"
RK: "They test 6 injections. I sure hope they increase to 12 and test toxicity as you'd like them too. Obviously by the math alone though your argument is debunked"
Bad math can't debunk! But okay I see what you're trying to say. And again, SAE and DLT are only partly related. There were two SAE in this study, one life threatening, and both "drug related." If they are to inject triple the lesions and according to you with double the injections what is your rationale for assuming SAE won't increase too??
RK: "As for my optimism, thanks for asking me to clear it up. Yes, I was very pleased with the case studies."
I could show you some VERY impressive case studies of a failed therapy. Much more impressive than some lesions swelling and then returning to baseline, while one continues growing, or some vague wording of a woman swimming again, or that someone had surgery WITHOUT significant shrinkage (not even a partial response), or that one has a very large lesion that also hasn't shrunk significantly (grew, shrunk, grew again) with pockets of necrosis. These are very weak cases. Want to see better ones? Just say yes and I'll show you. A handful of impressive partial responses and even a near CR but the therapy failed in future studies to show clinical benefit. Direct is miles behind even that.
I guess most of the longs in NWBO are pretty green in this sector. Please get advice from someone who understands the subject matter before risking too much money here! Percentage-wise, Woodford is risking VERY LITTLE. Good model to follow, so say you!
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